Aesculap Implant Systems LLC Recall 90484
Description: ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery.
Aesculap Implant Systems LLC Recall 90484 Information
| Status | Completed |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1391-2022 |
| Event ID | 90484 |
| Event Description | ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant surgery. |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA, MO, NC, OK, TX, WI. |
| Quantity | 67 |
| Recall Reason | Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring. |
| Device Classification | 20220727 |
| Device Code Info | UDI-DI (GTIN): 04046963419639 |
| Center Classification Date | 20220715 |
| Recall Initiation Date | 20191112 |
| Recalling Firm | Aesculap Implant Systems LLC |
| Initial Notification | Letter |
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